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Phase 3

  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    FDA issues Complete Response Letter for ITM-11 over manufacturing issues

    The FDA has issued a Complete Response Letter for ITM-11, [...]

    August 11, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    Adneuris licenses cebranopadol to Maruishi in $35M Japan and South Korea deal

    Adneuris Therapeutics has granted Maruishi Pharmaceutical exclusive rights to develop [...]

    August 7, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    Trixeo recommended for EU approval as asthma maintenance treatment

    AstraZeneca’s Trixeo Aerosphere has been recommended for approval in the [...]

    July 30, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    AB2 Bio receives $30 million as Nippon Shinyaku exercises US option for rare disease drug

    AB2 Bio will receive $30 million from Nippon Shinyaku after [...]

    July 30, 2026
  • Biotech & Pharma Business,Digital & Data,Drug Delivery & Formulation,Pharmaceuticals and therapeutics

    PolyPid’s D-PLEX100 receives FDA Priority Review for surgical site infection prevention

    PolyPid’s D-PLEX100 has been granted FDA Priority Review following acceptance [...]

    July 29, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    Telix starts Phase 3 trial of radiopharmaceutical therapy for renal cancer

    Telix has dosed the first patient in a Phase 3 [...]

    July 22, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    EMA accepts Almirall application to extend Ebglyss use in young children with atopic dermatitis

    The European Medicines Agency (EMA) has accepted Almirall’s application to [...]

    July 20, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    Adneuris licenses Phase 3 pain therapy cebranopadol to Conba for Greater China

    Adneuris Therapeutics has granted Zhejiang Conba Pharmaceutical exclusive rights to [...]

    July 15, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    EC approves first targeted first-line treatment for BRAF-mutant metastatic colorectal cancer

    The European Commission has approved Erbitux (cetuximab) in combination with [...]

    July 14, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    Merck wins FDA Breakthrough Therapy designation for lupus drug enpatoran

    Merck has received FDA Breakthrough Therapy designation for enpatoran, an [...]

    July 9, 2026
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